Pfizer Inc. announced positive results of a Phase 2 study of TRUMENBA® (Meningococcal Group B Vaccine) co-administered with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diptheria and pertussis (Tdap) vaccines in more than 2,600 healthy individuals 10 through 12 years of age. The study met its co-primary immunogenicity objectives regarding co-administration of TRUMENBA with MCV4 and Tdap vaccines. In addition, data from a recently completed Phase 3 study demonstrated the safety and tolerability of TRUMENBA in approximately 5,600 healthy individuals 10 through 25 years of age, and were consistent with data from studies that supported the October 2014 accelerated approval of TRUMENBA in the United States. Phase 2 Study Design: Vaccine safety, tolerability and immunogenicity were evaluated in this Phase 2, randomized, controlled, observer-blinded study of TRUMENBA® in the U.S. The study included more than 2,600 healthy individuals 10 through 12 years of age. Group 1 received TRUMENBA co-administered with MCV4 and Tdap vaccines; Group 2 received MCV4 and Tdap vaccines only; and Group 3 received TRUMENBA only. Co-primary objectives included: Demonstration that the immune response induced by MCV4 and Tdap vaccines given with TRUMENBA was noninferior to the immune response induced by MCV4 and Tdap vaccines alone when measured one month after the first vaccination; and Demonstration that the immune response induced by TRUMENBA given with MCV4 and Tdap vaccines was noninferior to the immune response induced by TRUMENBA alone, when measured one month after the third vaccination with TRUMENBA. Phase 3 Study Design: Vaccine safety and tolerability were evaluated in this Phase 3, randomized, controlled, double-blind study of TRUMENBA® in the U.S., Europe, Australia and Chile. The study, which was initiated in November 2012, included approximately 5,600 healthy individuals assigned in a 2:1 ratio to receive TRUMENBA in a 0, 2, 6 month schedule or control. The control group received a licensed hepatitis A vaccine at month 0 and 6 and saline at month 2. Subjects were followed for six (6) months after the last vaccination to assess safety and tolerability. Primary endpoints included: the percentage of individuals with one or more serious adverse event from the first study vaccination through six (6) months after the last study vaccination; and the percentage of individuals with one or more medically-attended adverse event within 30 days after each vaccination (at 1, 3 and 7 months). The rate of adverse events following vaccination with TRUMENBA was compared to those occurring in the control group. U.S. Indication for TRUMENBA® (Meningococcal Group B Vaccine): TRUMENBA® (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application (sNDA)for RAPAMUNE (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, anticipate a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act (PDUFA) action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus (MILES) Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE (dose adjusted to 5-15 ng/mL) or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second (FEV1). Full results of the MILES Trial were published in the New England Journal of Medicine. The most common adverse events reported during the study were mucositis, diarrhea, nausea, hypercholesterolemia, acneiform rash and swelling in the lower extremities. The adverse drug reactions observed were consistent with the known safety profile of RAPAMUNE in renal transplant patients, with the exception of weight decreased, which was reported at a greater incidence with RAPAMUNE compared to placebo.

Pfizer Announces FDA Acceptance for Review of a New Drug Application for ALO-02

Feb 13 15

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed.
Prescription opioids are an important treatment option for patients with chronic pain, but the misuse, abuse, and diversion of these agents remains a serious and persistent problem. Abuse deterrent opioid medications incorporate technology designed to make the product difficult to abuse, yet when used appropriately, provide patients with intended pain relief. Pfizer believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the U.S. Pfizer supports the appropriate use of opioid pain medications and is committed to research in this field. If approved, ALO-02 would become Pfizer’s second abuse deterrent formulation opioid. Pfizer’s submission to the FDA is based on the results of two Phase 3 trials in patients with moderate-to-severe, non-cancer chronic pain. In addition, Pfizer conducted three abuse-potential studies in recreational opioid users, comparing the abuse potential of crushed ALO-02 with immediate-release oxycodone when taken by the oral, intranasal or intravenous (the combination of oxycodone and 12% naltrexone was used to simulate crushed ALO-02 in the IV study) routes. ALO-02 capsules contain pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, the naltrexone remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released and is designed to counteract the effects of oxycodone.

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